A study to determine the feasibility of conducting a microbicide trial of daily vaginal gel and to inform the way adherence should be assessed

Brief summary describing the background
and objectives of the trial

Objectives: 1) To determine the feasibility of once-daily use of a vaginal microbicide gel 2) To inform the way adherence is assessed in a future clinical trial

Type of trial

RCT

Acronym (If the trial has an acronym then
please provide)

Disease(s) or condition(s) being studied

HIV/AIDS
,

Purpose of the trial

Prevention

Anticipated trial start date

2010-06-01

Actual trial start date

Anticipated date of last follow up

2010-09-30

Actual date of last follow up

Anticipated target sample size (number of
participants)

225

Actual target sample size (number of
participants)

Recruitment status

Not yet recruiting

Secondary Ids

Issuing authority/Trial register

Links to Secondary ID

STUDY DESIGN

Intervention assignment

Allocation to intervention

If randomised, describe how the
allocation sequence was generated

Describe how the allocation
sequence/code was concealed from the person
allocating the participants to the intervention arms

Masking

If masking / blinding was used

Parallel: different groups receive different interventions at same time during study

Randomised

Simple randomisation using a radomisation table created by a computer software program

Sealed opaque envelopes

Open-label (masking not used)

INTERVENTIONS

Intervention type

Intervention name

Dose

Duration

Intervention description

Group size

Nature of control

Experimental group

Group A

Daily insertion of 4ml HEC placebo gel

12 weeks

Return applicators daily

75

Experimental group

Group B

Daily insertion of 4ml HEC placebo gel

12 weeks

Return applicators weekly

75

Control group

Group C

Daily insertion of 4ml HEC placebo gel

12 weeks

Return applicators every 4 weeks

75

ELIGIBILITY CRITERIA

List inclusion criteria

List exclusion criteria

Min age

Max age

Gender

Women aged 18 years and above at enrolment
Likely to be sexually active at entry and during follow-up
Willing to use study gel as instructed
Willing to return applicators every week day
Willing to attend the clinic every 4 weeks and be interviewed
Willing to be followed up and interviewed if she defaults
Willing to receive health education about condoms
Willing to undergo pregnancy tests on a monthly basis
Willing and able to give informed consent

Using a product in a trial, or otherwise e.g. licensed spermicide, that is likely to impact on the outcome of this study and she is unwilling to stop use for the duration of study
Unable to agree a reliable method of contact with the field team
Likely to move out of the area within the next 3 months
Pregnant (including positive pregnancy test at enrolment)
Has clinical condition considered by the study management group to make enrolment inadvisable
Considered by the study personnel to be unlikely to be able to comply with the study procedures
Previously enrolled on MDP301 trial